360 DEGREE FIXATION LIGHT— 510(k) K933739

Substantially Equivalent

Varitronics

FDA 510(k) clearance K933739 for 360 DEGREE FIXATION LIGHT, Substantially Equivalent on 1994-03-14. Applicant: Varitronics. Device class: 1.

Clearance details

Applicant: Varitronics
Product code: Code HPL
Device class: Class 1
Regulation: 21 CFR 886.1290
Advisory panel: Ophthalmic
Date received: 1993-08-03
Decision date: 1994-03-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Broomall, PA, US

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Recent devices under product code HPL

K931731 — STORZ M824 FIXATION DEVICE FOR RETRACTIVE SURGERY1994-08-29
K873914 — ANIMATED FIXATION TOYS (DISTANCE AND NEARPOINT)1987-12-11
K854383 — KERATOLUX1985-11-12
K801381 — FITE FIXATION TOY FOR OCULAR EXAM1980-07-28
K800112 — AMBLYOPIA TRAINER1980-03-10

Data sourced from openFDA. This site is unofficial and independent of the FDA.